Non-compliant medical balloons for performing angioplasty and other medical procedures are known. U.S. Pat. No. 6,746,425 to Beckham discloses a non-compliant medical balloon and methods for manufacturing the balloon. U.S. Patent Application Publication No. US 2006/0085022 to Hayes et al. discloses a non-compliant medical balloon having an integral woven fabric layer and methods for manufacturing the balloon. U.S. Patent Application Publication No. US 2006/0085023 to Davies, Jr. et al. discloses a medical balloon having strengthening rods and methods for manufacturing the balloon. U.S. Patent Application Publication No. US 2006/0085024 to Pepper et al. discloses a non-compliant medical balloon having an integral non-woven fabric layer and methods for manufacturing the balloon. U.S. Pat. No. 6,746,425 and Publication Nos. US 2006/0085022, US 2006/0085023 and US 2006/0085024.
During an intervention, the balloon is inserted into a vessel, typically on the end of a catheter, until the balloon reaches the area of interest. Adding pressure to the balloon causes the balloon to inflate. In one variation of use, the balloon creates an outwardly directed force when inflated, which can be used to treat a variety of conditions.
As can be appreciated, different applications (such as for treating different vessels or parts of the body) may require the use of balloons having different diameters when inflated. Currently, manufacturers make multiple balloons available for use with different inflation diameters, and the clinician must select the appropriate balloon under a given set of conditions. In some cases, the number of balloons available may be more than twenty, ranging widely in diameter when inflated (e.g., from 12-26 millimeters) for a variety of different vessel diameters. This clearly increases the demands on manufacturers to provide the full variety of balloons that might be required for use with different sizes of vessels (which can vary at the sub-millimeter level), and also adds complexity to the selection process by the clinician given the large number of options available. While fully compliant balloons may be used to provide a variety of diameters under different inflation pressures, this compliance makes such a balloon generally ineffective for providing the treatment in the desired manner, especially where a significant force is required.
Thus, it would be desirable to provide a single balloon that can be adjusted (including in situ) to treat a variety of vessel diameters in an effective and reliable manner.